Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches

August 12, 2009 updated by: University of Toronto

This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.

The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:

  1. Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
  2. Do the acquired skills generalize and transfer?
  3. Are the skills maintained at 4 months post intervention?
  4. Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
  5. Does amount of parent involvement have any effect on skill acquisition or self efficacy?

Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:

- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • between 7 and 12 years of age
  • diagnosis of cerebral palsy with hemiplegia or spastic diplegia
  • Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
  • normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
  • child assent and agreement to participate
  • parental consent and agreement to participate
  • sufficient language ability to communicate with and be understood during treatment

Exclusion Criteria:

  • previously received or presently receiving a cognitive treatment for motor-based performance problems
  • use of alternative communication system such as PECS or communication board
  • regular use of BOTOX during intervention period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Toronto

Collaborators

Holland Bloorview Kids Rehabilitation Hospital
ErinoakKids

Investigators

  • Principal Investigator: Debra L Cameron, PhD. O.T., University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

January 30, 2007

First Submitted That Met QC Criteria

January 30, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

August 13, 2009

Last Update Submitted That Met QC Criteria

August 12, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BKR-06-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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